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Month: August 2023

FDA Revised its Final Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”

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On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

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On August 2, 2023, the U.S. Food and Drug Administration (FDA) published a Federal Register notice that modifications were being made to the Recognized Consensus Standards for Medical Devices database.

FDA Publishes Medical Device User Fees for Fiscal Year 2024

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On July 28, 2023, the U.S. Food and Drug Administration (FDA) posted a Federal Register notice announcing the User Fees for Fiscal Year 2024. The fees have increased by 9.5% and will be effective October 1, 2024.